晶型研究在口服固体制剂仿制药药学研发中的几点关注

Pharmaceutical Concerns on the Polymorphism Study in the Development of Oral Solid Generic Drugs

目的 阐述晶型研究在口服固体制剂仿制药药学研发中的关注点。方法 通过对目前申报资料的分析和思考,对原料药和固体制剂中原料药的晶型研究的考虑和方法进行探讨。结果与结论充分的晶型研究可以保证仿制药与参比制剂的治疗学等效以及仿制药的批间一致,是仿制药有效性、质量可控性的重要支持性研究。

OBJECTIVE The concerns of the polymorphism study on the development of oral solid generic drugs were stated in this article. METHODS Based on the analysisand thinking of the dossiers, the consideration and methodology of the polymorphism study on the drug substance and the drug product were discussed. RESULT AND CONCLUSION The therapeutical equivalence between generic drugs and reference drugs, as well as the between-batch consistence of generic drugs, could be partially guaranteed by adequate polymorphism study, which are the important supporting study on the efficiency and quality controllability of generic drugs.